Identity
- Trade Name
- NeuroStar Advanced Therapy System FDA UDI
- Generic Name
- Magnetic neural stimulation system FDA UDI
- Device Name
- NeuroStar Advanced Therapy System, recertified FDA UDI
- Model / Reference
- Version 3.6 FDA UDI
- Description
- NeuroStar Advanced Therapy System, recertified FDA UDI
Identifiers
- Catalog Number
- 81-03315-00R FDA UDI
- Primary DI / UDI-DI
- 00850005944812 FDA UDI
- FDA Product Code
- OBP FDA UDIQCI FDA UDI
- GMDN Term
- Magnetic neural stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5805 FDA UDI882.5802 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Magnetic neural stimulation system
NeuroStar Advanced Therapy System by Neuronetics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201158 also covers:
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar System Software — Neuronetics Inc.
- NeuroStar System Software — Neuronetics Inc.
- NeuroStar System Software — Neuronetics Inc.
K212289 also covers:
- Arm Support Cushion, Blue — Neuronetics Inc.
- Arm Support Cushion, Gray — Neuronetics Inc.
- Head Cushion Insert Set, Blue — Neuronetics Inc.
- Head Cushion Insert Set, Gray — Neuronetics Inc.
- Head Side Pad, 3 Pack — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neuronetics Inc.
Sources (1)
- FDA UDI 283ef206-0fe8-4885-82ba-42c0f48bc86b 36 fields · synced May 30, 2026